ELIANA
ELIANA was the global trial behind the first CAR-T approval: four in five children with no options left went into remission, and many stayed there for years.
75 infused (97 enrolled): ORR 81% at 3 months, all MRD-negative; 12-month EFS 50%, OS 76%; 5-year update: EFS 44% and OS 55% in the infused population with no further therapy in most responders. NEJM 2018; JCO 2023 update. Grade 3-4 CRS 46%.
- 81 out of 100 people reached this endpoint with Tisagenlecleucel.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 76 out of 100 people alive at 12 months with Tisagenlecleucel.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 55 out of 100 people alive at 5 years with Tisagenlecleucel.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- These results apply to the people the trial enrolled: Relapsed or refractory B-ALL, patients aged 3-25: single infusion of tisagenlecleucel. People in a different situation may not see the same effect.
- Only 97 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
97 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall remission rate within 3 monthsprimary | Tisagenlecleucel | 75 | 81% | — | — | link |
| Overall survival at 12 months | Tisagenlecleucel | — | 76% | — | — | — |
| Overall survival at 5 years | Tisagenlecleucel | — | 55% | — | — | link |
Pages like this
not linked directly; found by shared links- PersonCarl H. June
Shares Emily Whitehead, Tisagenlecleucel, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, CD19.
- PersonDavid L. Porter
Shares Emily Whitehead, Tisagenlecleucel, CD19, Acute lymphoblastic leukaemia.
- Key paperMaude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL
Shares Tisagenlecleucel, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19.
- ProductObecabtagene autoleucel
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.
- Key paperUCART19: the first gene-edited, donor-derived CAR-T cells in children and adults with relapsed B-cell ALL
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- PersonBruce L. Levine
Shares Emily Whitehead, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, CAR-T cell therapy.
- Key paperJULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma
Shares Tisagenlecleucel, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- InstitutionChildren's Hospital of Philadelphia
Shares Tisagenlecleucel, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.